FDA inspection
Isomedix Operations Inc.: FDA inspection ending Apr 13, 2016
FDA inspection 966619 · Voluntary Action Indicated (VAI) · Coon Rapids, MN
Key facts
| Inspection ID | 966619 |
|---|---|
| Firm | Isomedix Operations Inc. |
| FEI number | 2183744 |
| Address | 380 90th Ave Nw |
| City | Coon Rapids |
| State | MN |
| ZIP | 55433 |
| Country | United States |
| Fiscal year | 2016 |
| Inspection end date | Apr 13, 2016 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Compliance: Devices |
| Product type | Devices |
At a glance
- None Citations
- 1–9 Posted citations
- No Warning letter followed
- Yes Form FDA 483 issued
- No Establishment inspection report (EIR) exists
- 10–99 Inspections at this FEI
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA inspections
FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.
Source: U.S. Food and Drug Administration (FDA), inspection classification data